Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
3500 participants
OBSERVATIONAL
2021-02-08
2024-01-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Bronchiolitis
\- Children under 24 months of age (≤) with First episode of bronchiolitis.
Aims :
\- For city physicians: Enrrollment of 1000 children with Bronchiolitis not associated with otitis
\- In the hospital (at pediatric emergencies): Enrrollment of 900 children with bronchiolitis
nasopharyngeal samples
rapid antigen test for Sars Cov-2, influenza and RSV. multiplex RT-PCR for a subgroup of 500 patients
Acute otitis media
Define with Paradise Criteria) or otorrhea
Enrrollment only for city physicians :
* 500 children with Otitis not associated with Bronchiolitis
* 500 children with Otitis associated with Bronchiolitis
nasopharyngeal samples
rapid antigen test for Sars Cov-2, influenza and RSV. multiplex RT-PCR for a subgroup of 500 patients
Pneumonia
Defined by the presence of opacity of parenchymal condensation and/or pleural effusion on chest X-ray associated with fever.
Aims:
\- For city physicians: Enrrollment of 100 children with pneumonia
\- In the hospital (pediatric emergencies): Enrollment of 500 children with pneumonia
nasopharyngeal samples
rapid antigen test for Sars Cov-2, influenza and RSV. multiplex RT-PCR for a subgroup of 500 patients
Interventions
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nasopharyngeal samples
rapid antigen test for Sars Cov-2, influenza and RSV. multiplex RT-PCR for a subgroup of 500 patients
Eligibility Criteria
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Inclusion Criteria
* One of the holders of parental authority signed the consent
* Patient affiliated to a social security scheme (Social Security or Universal Medical Coverage)
* First episode of bronchiolitis defined by
* Age ≤24 months
* At least one symptom from group A and one symptom from group B Group A (one or more)
* Fever \>38 °C
* Cough
* Otalgia
* Nasal congestion
* Rhinorrhea
* Coryza
* Dysphagia Group B (one or more)
* whistling
* Crackles
* Rales
* Decrease in respiratory noise
* Shortness of breath
* Dyspnea
* OR Acute purulent otitis media (Paradise Criteria) or otorrhea.
* OR Pneumonia defined by the presence of opacity of parenchymal condensation and/or pleural effusion on chest X-ray associated with fever
Exclusion Criteria
* Refusal by one of the parents
* Not affiliated to a social security system
1 Day
24 Months
ALL
No
Sponsors
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Sanofi
INDUSTRY
Association Clinique Thérapeutique Infantile du val de Marne
OTHER
Responsible Party
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Locations
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ACTIV
Créteil, , France
Countries
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Central Contacts
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Facility Contacts
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Corinne Levy, MD
Role: primary
Stéphane Béchet, MSc
Role: backup
References
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Rybak A, Levy C, Jung C, Bechet S, Batard C, Hassid F, Zouari M, Cahn-Sellem F, Bangert M, Cohen R. Delayed Bronchiolitis Epidemic in French Primary Care Setting Driven by Respiratory Syncytial Virus: Preliminary Data from the Oursyn Study, March 2021. Pediatr Infect Dis J. 2021 Dec 1;40(12):e511-e514. doi: 10.1097/INF.0000000000003270.
Lenglart L, Levy C, Basmaci R, Levieux K, Kramer R, Mari K, Bechet S, Launay E, Cohen L, Aupiais C, de Pontual L, Rybak A, Lassoued Y, Ouldali N, Cohen R. Nirsevimab effectiveness on paediatric emergency visits for RSV bronchiolitis: a test-negative design study. Eur J Pediatr. 2025 Feb 1;184(2):171. doi: 10.1007/s00431-025-06008-9.
Related Links
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Delayed Bronchiolitis Epidemic in French Primary Care Setting Driven by Respiratory Syncytial Virus: Preliminary Data from the Oursyn Study, March 2021
Other Identifiers
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2020-A02876-33
Identifier Type: -
Identifier Source: org_study_id